Enoxaparin Sodium CAS No 679809-58-6

China Enoxaparin Sodium CAS No 679809-58-6, Find details about China Enoxaparin Sodium, 679809-58-6 from Enoxaparin Sodium CAS No 679809-58-6

Model NO.
SAMREAL-0201
Trademark
samreal
Origin
China
Model NO.
SAMREAL-0201
Trademark
samreal
Origin
China

Enoxaparin Sodium CAS No 679809-58-6
Enoxaparin Sodium CAS No 679809-58-6
 
Product NameEnoxaparin sodiumGradeInjectable
According toEP 9.0
ItemsStandardsResults
Characters A white or almost white powderAlmost white powder
Solubility Freely soluble in waterComplies
Identification Examine by nuclear magnetic resonance spectrometryThe spectrum obtained with the test solution is similar to specific low-molecular-mass heparin CRS.Complies
1,6-anhydro derivatives15%-25%23.0%
The ratio of anti-factor Xa activity to anti-factor II a activity3.3-5.34.8
Molecular distribution`Mw:3800-5000
<2000:12.0%-20.0%
2000-8000:68.0%-82.0%
4633
17.8%
70.1%
Reaction of sodiumIt gives reaction of sodiumComplies
Appearance of solutionClear and not more than intensity 6Complies
PH6.2-7.76.9
Nitrogen1.5%-2.5%(Dry)2.0%
Heavy metals30ppm<30ppm
Luminous absortion14.0-20.017.0
Benzyl alcohol0.1%(m/m)0.01%
Sodium11.3%-13.5%(Dry)12.3%
Residual solventEthanol:5000ppm
Methanol:3000ppm
Dichloromethane:600ppm
4000ppm
40ppm
Not detectable
Molar ratio of sulphate ions to carboxylate ions 1.82.1
Loss on drying10.0%0.9%
Bacterial endotoxin0.01 EU/A Xa IU<0.01 EU/A Xa IU
Microbiological examinationTotal viable aerobic count:100cfu/g
Fungi count:10cfu/g
No pathogenic microorganisms(Escherichiacoil,Staphylococcus Aureus,Salmonella Species,Pseudomonas Aeruginosa,Bile-Tolerant Gram-Negative Bacteria)
<10cfu/g

<10cfu/g


Not detectable


 
Anti-factor II a activity20 IU/mg-35IU/mg(Dry)25IU/mg(wet 25 IU/mg)
Anti-factor Xa activity90IU/mg-125IU/mg(Dry)119IU/mg(wet 118 IU/mg)
Enoxaparin Sodium CAS No 679809-58-6
Enoxaparin Sodium CAS No 679809-58-6
Enoxaparin Sodium CAS No 679809-58-6